Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Use of hydrocodone and pseudoephedrine combination is not indicated in children younger than 18 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of hydrocodone and pseudoephedrine combination in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Pregnancy

Information about this hydrocodone-and-pseudoephedrine-oral-route

Pregnancy Category

Explanation

All Trimesters

C

Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Clorgyline

Dihydroergotamine

Furazolidone

Iproniazid

Isocarboxazid

Linezolid

Moclobemide

Naltrexone

Nialamide

Pargyline

Phenelzine

Procarbazine

Rasagiline

Selegiline

Toloxatone

Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abiraterone

Acetophenazine

Alfentanil

Alprazolam

Amobarbital

Amprenavir

Anileridine

Aprepitant

Aprobarbital

Atazanavir

Baclofen

Boceprevir

Bosentan

Bromazepam

Brotizolam

Buprenorphine

Buspirone

Butabarbital

Butalbital

Butorphanol

Carbamazepine

Carbinoxamine

Carisoprodol

Ceritinib

Chloral Hydrate

Chlordiazepoxide

Chlorpromazine

Chlorzoxazone

Ciprofloxacin

Clarithromycin

Clobazam

Clonazepam

Clorazepate

Cobicistat

Codeine

Conivaptan

Crizotinib

Cyclobenzaprine

Dabrafenib

Dantrolene

Darunavir

Delavirdine

Dexamethasone

Dexmedetomidine

Dezocine

Diacetylmorphine

Diazepam

Difenoxin

Dihydrocodeine

Diltiazem

Diphenhydramine

Diphenoxylate

Dixyrazine

Donepezil

Doxylamine

Dronedarone

Efavirenz

Enzalutamide

Erythromycin

Eslicarbazepine Acetate

Estazolam

Eszopiclone

Ethchlorvynol

Ethopropazine

Ethylmorphine

Etravirine

Fentanyl

Fluconazole

Flunitrazepam

Fluphenazine

Flurazepam

Fosamprenavir

Fosaprepitant

Fosphenytoin

Fospropofol

Furazolidone

Guanethidine

Halazepam

Hexobarbital

Hydromorphone

Hydroxyzine

Idelalisib

Imatinib

Indinavir

Iobenguane I 123

Iproniazid

Isocarboxazid

Itraconazole

Ketazolam

Ketobemidone

Ketoconazole

Levorphanol

Linezolid

Lomitapide

Lopinavir

Lorazepam

Lormetazepam

Loxapine

Meclizine

Medazepam

Meperidine

Mephenesin

Mephobarbital

Meprobamate

Meptazinol

Mesoridazine

Metaxalone

Methadone

Methdilazine

Methocarbamol

Methohexital

Methotrimeprazine

Methyldopa

Methylene Blue

Metopimazine

Miconazole

Midazolam

Midodrine

Mifepristone

Mitotane

Moclobemide

Modafinil

Morphine

Morphine Sulfate Liposome

Nafcillin

Nalbuphine

Nefazodone

Nelfinavir

Nevirapine

Nicomorphine

Nilotinib

Nitrazepam

Opium

Opium Alkaloids

Orphenadrine

Oxazepam

Oxcarbazepine

Oxycodone

Oxymorphone

Papaveretum

Paregoric

Pentazocine

Pentobarbital

Perampanel

Perazine

Periciazine

Perphenazine

Phenelzine

Phenobarbital

Phenytoin

Piperaquine

Pipotiazine

Piritramide

Posaconazole

Prazepam

Prednisolone

Prednisone

Primidone

Procarbazine

Prochlorperazine

Promazine

Promethazine

Propiomazine

Propofol

Quazepam

Ramelteon

Rasagiline

Regorafenib

Remifentanil

Rifabutin

Rifampin

Rifapentine

Ritonavir

Saquinavir

Secobarbital

Selegiline

Siltuximab

Sodium Oxybate

St John's Wort

Sufentanil

Suvorexant

Tapentadol

Telaprevir

Telithromycin

Temazepam

Thiethylperazine

Thiopental

Thiopropazate

Thioproperazine

Thioridazine

Ticagrelor

Tilidine

Tipranavir

Tizanidine

Topiramate

Tramadol

Tranylcypromine

Triazolam

Triflupromazine

Trimeprazine

Verapamil

Voriconazole

Zaleplon

Zolpidem

Zopiclone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Escitalopram

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Addison's disease (adrenal gland problem) or

Asthma or

Diabetes or

Drug dependence, especially narcotic abuse or dependence, or history of or

Enlarged prostate (BPH, prostatic hypertrophy) or

Problems with passing urine or

Thyroid disease—Use with caution. May increase risk for more serious side effects.

Heart disease (e.g., coronary artery disease), severe or

Hypertension (high blood pressure), severe or

Narrow angle glaucoma or

Urinary retention—Should not be used in patients with these conditions.

Kidney disease, severe or

Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.